Magnetic Stimulation for Stress Urinary Incontinence

Overseen By Razia Sultana, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Pregnancy, Urgency UI, Chemo, others

Compensation: Varies

Number of Visits: 9

Duration: 3 weeks

158 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot have any concurrent or new planned treatment for stress urinary incontinence during the treatment period and the 3 months following it.

What data supports the effectiveness of the treatment Magnetic Stimulation for Stress Urinary Incontinence?

Research shows that pulsed magnetic stimulation can improve the quality of life for women with stress urinary incontinence and is perceived positively by patients. Additionally, it has been effective in cases where other treatments like pelvic floor muscle training have not worked. ^{1 2 3 4 5}

Is magnetic stimulation safe for treating stress urinary incontinence?

Research shows that magnetic stimulation for urinary incontinence is generally safe, with minimal and temporary side effects reported. Most studies found no side effects, and it is considered one of the safest non-surgical treatments for urinary incontinence. ^{2 3 6 7 8}

How does magnetic stimulation treatment for stress urinary incontinence differ from other treatments?

Magnetic stimulation for stress urinary incontinence is unique because it uses electromagnetic fields to stimulate muscles, which is different from traditional treatments like pelvic floor exercises or surgery. This non-invasive approach can be an alternative for those who prefer not to undergo surgery or take medication. ^{1 2 8 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to determine the efficacy of electromagnetic stimulation treatment of the pelvic floor muscles in adult females with stress urinary incontinence.

Research Team

P Lee, MD

Principal Investigator

Sunnybrook Health Sciences Centre,, University of Toronto

Eligibility Criteria

This trial is for adult females with stress urinary incontinence, who are not pregnant or planning pregnancy, without metal implants from umbilicus to knees. Participants should have no recent pelvic treatments and be able to follow the study protocol. Exclusions include those on current chemo/radiotherapy, with systemic diseases affecting bladder function, or other types of urinary incontinence.

Inclusion Criteria

I am not planning any treatment for stress urinary incontinence soon.

I am not pregnant and do not plan to become pregnant during the study.

I can empty my bladder well and have minimal pelvic organ drop.

Exclusion Criteria

My pad weight increase is less than 3 grams in a 24-hour test.

I am currently being treated for chronic pelvic pain.

You have metal in your body from the waist to the knees, or a heart pacemaker.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either magnetic stimulation therapy or sham therapy for stress urinary incontinence

3 weeks

6 visits (in-person)

Open-label extension

Sham treatment arm participants who do not meet treatment success may receive open-label magnetic stimulation therapy

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular follow-up visits at 3, 6, 12, and 24 months

Treatment Details

Interventions

• Magnetic Stimulation
• Sham Magnetic Stimulation

Trial Overview The trial tests if electromagnetic stimulation can help women with stress urinary incontinence by strengthening their pelvic floor muscles. It compares real magnetic stimulation treatment against a sham (fake) procedure to see if there's an actual benefit.

Participant Groups

Group I: Magnetic stimulation therapy Active Control 1 Intervention

Participants will sit fully clothed on the magnetic stimulator chair, with knees apart at about the width of their shoulders, feet flat on the floor. The stimulator will be activated and the intensity gradually increased as tolerated by the participant up to an intensity of 100%. There are a total of 6 treatment sessions (twice per week) over 3 weeks.

Group II: Sham therapy Placebo Group 1 Intervention

Participants will sit fully clothed on the magnetic stimulator chair, with knees apart at about the width of their shoulders, feet flat on the floor. The stimulator will be activated and the intensity gradually increased as tolerated by the participant up to an intensity of 5%. There are a total of 6 treatment sessions (twice per week) over 3 weeks.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario

Collaborator

Trials

2

Recruited

220+

Findings from Research

In a study of 25 patients with stress urinary incontinence, flat magnetic stimulation significantly improved objective measures of continence, which remained effective even at a 3-month follow-up.

However, subjective quality of life scores returned to baseline levels three months after treatment, suggesting that additional treatment cycles may be necessary to maintain benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flat Magnetic Stimulation for Stress Urinary Incontinence: A 3-Month Follow-Up Study. Barba, M., Cola, A., Rezzan, G., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of electromagnetic therapy for urinary incontinence: A systematic review. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Patients' perception and satisfaction with pulsed magnetic stimulation for treatment of female stress urinary incontinence. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Effect of pulsed magnetic stimulation on quality of life of female patients with stress urinary incontinence: an IDEAL-D stage 2b study. [2018]

5. Australia pubmed.ncbi.nlm.nih.gov

Effects of magnetic stimulation on urodynamic stress incontinence refractory to pelvic floor muscle training in a randomized sham-controlled study. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Possible Side Effects in the Treatment of Urinary Incontinence with Magnetic Stimulation. [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

Multicenter, randomized, sham-controlled study on the efficacy of magnetic stimulation for women with urgency urinary incontinence. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Functional magnetic stimulation for mixed urinary incontinence. [2008]

9. United States pubmed.ncbi.nlm.nih.gov

Long-term sacral magnetic stimulation for refractory stress urinary incontinence. [2015]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Flat Magnetic Stimulation for Stress Urinary Incontinence: A 3-Month Follow-Up Study. [2023]